IMOVAX POLIO, suspension for injection in a prefilled syringe. Poliomyelitis vaccine (inactivated)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN

Available from:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC code:

J07BF03

INN (International Name):

POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2007-02-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINAL PRODUCT
IMOVAX POLIO, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
POLIOMYELITIS VACCINE (INACTIVATED)
BOXED TEXT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED, BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told
you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What IMOVAX POLIO, suspension for injection in prefilled syringe is
and what it is used for
2.
What you need to know before you use IMOVAX POLIO, suspension for
injection in prefilled syringe
3.
How to use IMOVAX POLIO, suspension for injection in prefilled syringe
4.
Possible side effects
5.
How to store IMOVAX POLIO, suspension for injection in prefilled
syringe
6.
Contents of the pack and other information
1.
WHAT IMOVAX POLIO, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE IS
AND WHAT IT IS USED
FOR
PHARMACOTHERAPEUTIC GROUP: VACCINE AGAINST POLIOMYELITIS - ATC CODE:
J07BF03
IMOVAX POLIO is a vaccine. Vaccines are used to protect against
infectious diseases.
When IMOVAX POLIO is injected, the body’s natural defences develop a
protection against those diseases.
This vaccine is indicated for the prevention of poliomyelitis in
infants, children and adults, for primary vaccination
(series of first vaccinations) and as a booster.
IMOVAX POLIO must be used according to effective official
recommendations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMOVAX POLIO, SUSPENSION FOR
INJECTION IN
PREFILLED SYRINGE
DO NOT USE IMOVAX POLIO, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
IF YOU OR YOUR CHILD:
•
are allergic (hypersensitive) to the active substances or to any of
the other components of IM

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
IMOVAX POLIO, SUSPENSION FOR INJECTION IN PREFILLED
SYRINGE POLIOMYELITIS VACCINE (INACTIVATED)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
Poliomyelitis virus
(inactivated)
Type 1 (Mahoney strain)#
............................................................................................................
29 D-antigen units*
Type 2 (MEF-1 strain)#
..................................................................................................................
7 D-antigen units*
Type 3 (Saukett strain)#
...............................................................................................................
26 D-antigen units*
This vaccine complies with European Pharmacopoeia requirements and WHO
recommendations.
# Cultivated on VERO cells
* These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-
antigen units, for virus type 1, 2 and 3 respectively, when measured
by another suitable
immunochemical method
Excipients with known effect
Phenylalanine……………12.5 micrograms
Ethanol…………….…….2 milligrams
(See section 4.4)
IMOVAX POLIO may contain traces of neomycin, streptomycin and
polymyxin B (see
section 4.3). For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
IMOVAX POLIO is a clear and colourless suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This vaccine is indicated for the prevention of poliomyelitis in
infants, children and adults, for
primary and booster vaccination.
IMOVAX POLIO must be used according to effective official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Paediatric population _
Dosage regimen compliant with French recommendations:
•
2 injections at an interval of two months, one at the age of 2 months
and one at the age of
4 months (primary vaccination) followed by a first booster at the age
of 11 months.
Other dosage regimens co